Subcutaneous catheter stabilizing devices and methods for securing a catheter using the same

ABSTRACT

Locatable devices are provided for subcutaneously securing a catheter in an area to be catheterized. In addition, methods for securing a catheter in a subcutaneous location are also provided. In one embodiment, the device comprises two releasably lockable arcuate members interconnected by a hinge. The ends of the arcuate members move with respect to one another from a closed position in which the side surfaces of the arcuate members are coupled in a facing relationship forming a tubular base with a longitudinal passage for receiving a catheter, to an open position in which the ends of the arcuate members are uncoupled and at least partially spaced from each other. Each member is fastened to an end of a connecting material. The connecting material has a length such that it extends within the passage and forms a tightened loop around a catheter inserted within the device. The device may alternatively comprise two tubular members which rotate about each other to create a tightened loop of connecting material around a catheter in a generally cylindrical passage, or an elastic base and a connecting material which forms a loop around a catheter while the base is in a flexed open position and tightens around the catheter while the base is in a relaxed closed position.

FIELD OF THE INVENTION

The present invention relates to locatable devices for subcutaneouslysecuring a catheter and methods for subcutaneously securing a catheter,with a locatable device which can be located in any stable position forsecurement.

BACKGROUND OF THE INVENTION

Catheters may be located in various venous locations and cavitiesthroughout the body. Central venous catheters, for example, are placedin four common locations within the chest and/or in the femoral vessels.They may be placed in either the right or left subclavian vein or in theright or left internal jugular vein.

In order to place a catheter in a particular location, a physician usesvarious techniques. To determine the location of some vessels, forexample, a physician may predict the location by physical body landmarkspresent on the body surface for vessels which are not themselves visibleon the body surface. Using landmarks, vessels may be cannulated by firstidentifying the vessels by aspiration with a long hollow needle. Whenblood enters a syringe attached to the needle, the syringe isdisconnected and a guide wire is passed through the needle into thehollow passage, or lumen, of the vessel. The needle is then removedleaving the guide wire within the vessel. The guide wire projects beyondthe surface of the skin.

Several options are then available to a physician for venous catheterplacement. The simplest is to pass a catheter into the vessel directlyover the guide wire. The guide wire is then removed leaving the catheterin position within the vessel. This technique is typically used when thecatheter is of a relatively small diameter, made of a stiff material andnot significantly larger than the guide wire. If the catheter issignificantly larger than the guide wire, a dilator device is firstpassed over the guide wire to enlarge the hole following which thecatheter is passed over the guide wire and the guide wire removed.

A further option requires an introducer sheath. This is simply a large,stiff thin-walled catheter which serves as a temporary conduit for thepermanent catheter which is being placed. The introducer sheath ispositioned by placing a dilator device inside of the introducer andpassing both the dilator and the introducer together into the vessel.The guide wire and dilator are then removed leaving the thin-walledintroducer sheath in place. A catheter such as a Swan-Ganz catheter intowhich a guide wire cannot be placed or a large silicone catheter such asa Tesio catheter can then be placed through this dilator sheath.

In the case of the Swan-Ganz catheter, the introducer sheath has ahemostasis valve at its proximal end and is simply left in place tofunction as part of the intravenous system.

In the case of a Tesio catheter, a physician would not leave the stiff,thin-walled catheter in place. Therefore, a straight catheter without ahub or an anchoring device is passed through the sheath and into thevessel. The sheath is removed over the catheter. However, if a hub orany type of anchoring device such as a cuff is permanently attached tothe catheter, the sheath must be very large or comprise a tear-awayportion which splits into two parts as the sheath is retracted.

Although the larger or the tear-away sheaths work, they are associatedwith unwanted bleeding and the tear-away sheath tends to pull thecatheter out of the vein as the sheath is removed. As a result, there isa need in the art for an anchoring device which can be utilized afterthe sheath has been removed which enables a physician to use a preferredsmall diameter, non-tear-away sheath for insertion of certain venouscatheters which eliminates the disadvantages associated with largediameter or tear-away sheaths.

A typical anchoring device for these catheters and other venous and bodycavity catheters and shunts involves use of a tissue ingrowth cufffitted on the catheter for stabilization of a catheter in a singleposition if the catheter is to be left in that position for asignificant length of time. Surrounding tissue cells grow into thefabric stabilizing the catheter in a particular location. In usingcatheters having fabric cuff fittings, it is common to create asubcutaneous tunnel or similar opening several centimeters caudal to theinsertion site of the catheter for stabilization of the catheter usingthe cuff. Subcutaneous tunnels are typically used with insertion ofTesio catheters, for example.

Once the catheter is inserted in a blood vessel or other location, theskin is anaesthetized in a linear fashion for a distance of about 6-8centimeters caudal to the insertion site. If tunneling is used forvenous insertion, a second incision is made and a tunneling device ispassed into the incision and out through the skin at the point ofcatheter insertion creating a subcutaneous tunnel. The catheter isattached to the tunneling device and pulled back through the skintunnel. A cuff is typically designed to lie in the medial portion of thesubcutaneous tunnel. Similarly, when inserting catheters in bodycavities and other locations, some catheters are designed such that thecuff is affixed to the catheter in an area which corresponds to atypical area chosen by a physician for subcutaneous securement.

While providing satisfactory anchoring in some situations, cathetersmanufactured with fabric cuffs already affixed are only available inseveral set lengths having the cuffs located in areas designed tocorrespond to average patient sizes. The cuffs are not, adjustable toall body sizes and types for optimal positioning. The cuffs are notlocatable or movable along the catheter to adjust for placementdiscrepancies. As most patients vary in size, internal distancesinvolved in subcutaneous placement vary accordingly, deviating from thestandard catheter cuff locations commercially available and makingstable securement difficult in many cases.

In addition, as the cuff cannot be moved, the physician may have toadjust the catheter itself within the vein to align the cuff within astable area for securement. Positioning of the catheter is particularlyimportant to proper catheter functioning. For example, if the tip of acentral venous catheter is not properly located within a vessel, thecatheter may cause the condition of cardiac arrhythmia or otherwiseinhibit blood flow. If the catheter tip is not properly located within abody cavity there may not be sufficient access to the tip to allowbodily fluid to properly flow through the catheter.

A need is therefore present for an anchoring device which is locatablewithin a subcutaneous tunnel or other subcutaneous location for securinga catheter such that the device can be placed by the physician in themost stable position for subcutaneous securement of the catheter withoutthe need to move the catheter itself or to depend upon availablecommercial sizes of catheters having cuffs already affixed in positionsfor only average patient sizes. It is also preferable to have ananchoring device which is attachable after insertion of a catheter toobviate the need for large diameter or tear-away sheaths used withcertain catheters.

SUMMARY OF THE INVENTION

The present invention comprises a device for subcutaneously securing acatheter in an area to be catheterized. The device comprises a locatabledevice that includes a first and a second arcuate member. Each arcuatemember has an exterior and an interior surface as well as a sidesurface. The side surface of the first arcuate member is in facingrelationship to the side surface of the second arcuate member. A hingeinterconnects the first and second arcuate members such that the firstarcuate member may move with respect to the second arcuate memberbetween closed and open positions. In the closed position, the sidesurfaces of the first and second arcuate members are coupled in facingrelationship such that a tubular base is formed. The base defines apassage which extends longitudinally through the base for receiving acatheter. In the open position, the first and second arcuate members areuncoupled and at least partially spaced from each other. In addition,the side surfaces of the first and second arcuate members are releasablylockable in the closed position. A connecting material extends withinthe passage of the device. The connecting material has a first and asecond end. The first end is fastened to the first arcuate member, andthe second end is fastened to the second arcuate member. The connectingmaterial has a length measured between the first and second ends suchthat when the first and second arcuate members are in the closedposition, the connecting material forms a tightened loop at leastpartially around the catheter thereby securing the catheter within thedevice and maintaining free flow of bodily fluid through the catheter.

The present invention also includes a method for subcutaneous securementof a catheter inserted into an area to be catheterized using a devicewhich comprises a locatable device that includes a first and secondarcuate member interconnected by a hinge and a connecting materialattached at a first end to the first arcuate member and at a second endto the second arcuate member. The method comprises the steps ofinserting a distal portion of a catheter into an area to becatheterized. The device is opened such that a space is created betweenthe first and second arcuate members sufficient to receive a catheter. Aportion of the catheter proximal the distal portion is inserted throughthe space such that the proximal portion of the catheter is between theinterior surfaces of the first and second arcuate members. Theconnecting material is between the proximal portion of the catheter andthe firsthand second arcuate members. The device is moved along theproximal portion until the device is positioned in a stable area forsecurement. The first and second arcuate members are moved about thehinge to a closed position such that the first arcuate member is coupledin facing relationship with the second arcuate member. The connectingmaterial forms a tightened loop around the catheter securing thecatheter within the device and maintaining free flow of bodily fluidwithin the catheter.

In an alternative embodiment, the device of the present inventioncomprises a first tubular member, a second tubular member, andconnecting material. The first tubular member has an exterior surfaceand an interior surface which defines a passage extending longitudinallythrough the first tubular member. The second tubular member has anexterior surface and an interior surface which defines a passageextending longitudinally through the second tubular member. At least aportion of the first tubular member is positioned within the passage ofthe second tubular member such that a space lies between the exteriorsurface of the first tubular member and the interior surface of thesecond tubular member. The first tubular member has a hole extendingfrom its exterior to its interior surface. The connecting material isfastened at a first end to the interior surface of the first tubularmember. The connecting material has a second end which passes outwardlythrough the hole and is fastened to the second tubular member. A lengthof the connecting material within the passage of the first tubularmember is formed into a loop, whereby when a catheter is positionedwithin the loop, the second tubular member is rotated with respect tothe first tubular member to pull a portion of the length of theconnecting material within the passage of the first tubular member intothe space between the members and to tighten the loop around thecatheter thereby securing the catheter within, the passage of the firsttubular member and maintaining free flow of bodily fluid through thecatheter.

The present invention also comprises an alternative method forsubcutaneous securement of a catheter inserted into an area to becatheterized using a device which comprises a locatable device includingfirst and second tubular members. The first tubular member is positionedwithin a passage extending longitudinally through the second tubularmember. The device comprises a connecting material which has one endfastened to an interior surface of the first tubular member and a secondend passing outwardly through a hole in the first tubular member andfastened to the second tubular member. The method comprises the steps ofinserting a distal portion of a catheter in an area to be catheterized.A length of connecting material is formed within a passage extendinglongitudinally through the first tubular member into a loop. A portionof the catheter proximal the distal portion is then inserted through theloop within the passage of the first tubular member. The loop and deviceare moved along the proximal portion until the device is positioned in astable area for securement. The second tubular member is rotated withrespect to the first tubular member to pull a portion of the length ofthe connecting material in the passage of the first tubular member intoa space between the members to tighten the loop around the catheterthereby securing the catheter within the passage of the first tubularmember and maintaining free flow of bodily fluid through the catheter.

The present invention further comprises an alternative embodiment inwhich the device of the present invention comprises an elastic basehaving an exterior surface, an interior surface, a first side surfaceand a second side surface opposite the first side surface. The base ismovable from a flexed open position to a relaxed closed tubular positionin which the first and second side surfaces are proximate each other,and the base defines a longitudinal passage for receiving a catheter.The device further comprises a first suture hole spaced from the firstside surface, and a second suture hole spaced from the second sidesurface. A connecting material is drawn at a first end through the firstsuture hole from the interior surface to the exterior surface of thebase, and at a second end through the second suture hole from theinterior surface to the exterior surface of the base. When the base isin the flexed open position, the catheter is insertable between theinterior surface of the base and the connecting material and when thebase is in the relaxed closed position, the connecting material forms atleast a portion of a loop which at least partially surrounds thecatheter. The first and second ends of the connecting material arefastened thereby tightening the connecting material and securing thecatheter within the passage of the base while maintaining free flow ofbodily fluid through the catheter.

A further alternative method for subcutaneous securement of a catheterinserted into an area to be catheterized is also provided in the presentinvention. The method uses a locatable device which comprises an elasticbase, a first suture hole spaced from the first side surface of the baseand a second suture hole spaced from the second side surface of thebase. A connecting material is drawn at a first end outwardly throughthe first suture hole and at a second end outwardly through the secondsuture hole. The base is movable from a flexed open position to arelaxed closed tubular position. The method comprises the steps ofinserting a distal portion of the catheter into the area to becatheterized. The base is moved to and maintained in the flexed openposition. A portion of the catheter proximal the distal portion isinserted between the connecting material and the base. At least aportion of a loop which at least partially surrounds the catheter isthen formed, and the base is released such that it moves to the relaxedclosed position. The first and the second ends of the connectingmaterial are fastened to each other to tighten the connecting materialand secure the catheter within the base. The device maintains the freeflow of bodily fluid through the catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofpreferred embodiments of the invention, will be better understood whenread in conjunction with the appended drawings. For the purpose ofillustrating the invention, there is shown in the drawings embodimentswhich are presently preferred. It should be understood, however, thatthe invention is not limited to the precise arrangements andinstrumentalities shown. In the drawings, like numerals are used toindicate like elements throughout. In the drawings:

FIG. 1 is a perspective view of a preferred embodiment of a locatabledevice for subcutaneous securement of a catheter in an area to becatheterized according to the present invention in the closed position;

FIG. 1a is a perspective view of a preferred embodiment of a locatabledevice for subcutaneous securement of a catheter in an area to becatheterized according to the present invention in the closed position;

FIG. 2 is a front elevational view of the device of FIG. 1;

FIG. 2a is a front elevational view of the device of FIG. 1a;

FIG. 3 is a perspective view of the device of FIG. 1 in the openposition;

FIG. 3a is a perspective view of the device of FIG. 1a in the openposition;

FIG. 4 is a perspective view of the device of FIG. 1 having a fabriccovering and enclosed around a catheter;

FIG. 4a is a perspective view of the device of FIG. 1a having a fabriccovering and enclosed around a catheter;

FIG. 5 is a front elevational view of an alternative preferredembodiment of a locatable device for subcutaneous securement of acatheter in an area to be catheterized according to the presentinvention;

FIG. 6 is a perspective view of the device of FIG. 5 enclosed around acatheter;

FIG. 7 is a diagrammatic view showing a preferred system for securingtwo catheters in two separate subcutaneous locations using two devicesaccording to a preferred embodiment of the present invention.

FIG. 8 is a perspective view of an alternative preferred embodiment of alocatable device for subcutaneous securement of a catheter in an area tobe catheterized according to the present invention in an open position;

FIG. 9 is a perspective view of the device of FIG. 8 forming a looparound a catheter; and

FIG. 10 is a perspective view of the device of FIG. 8 enclosed around acatheter.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Certain terminology is Used in the following description for convenienceonly and is not limiting. The words "right," "left," "lower" and "upper"designate , directions in the drawings to which reference is made. Thewords "inwardly" and "outwardly" refer to directions toward and awayfrom, respectively, for example, the metric center of the locatabledevice and parts thereof. The terminology includes the words abovespecifically mentioned, derivatives thereof, and words of similarimport.

Referring now to the drawings in detail, where like numerals indicatelike elements throughout, there are shown in FIGS. 1 through 4 and 1athrough 4a, a preferred embodiment of a locatable device forsubcutaneous securement of a catheter in an area to be catheterized.Once a catheter is properly inserted in an area to be catheterized, thedevice, not the catheter, is moved to an optimal location for cathetersecurement thereby ensuring optimal tip location. In addition, thedevice is placed on the catheter after insertion enabling large diametercatheters and those having detachable hubs or other attachments to beused in conjunction with small diameter, non-tear-away introducersheaths.

The device (hereinafter "cuff"), generally designated 10, is comprisedof a tubular base 11 and a covering of fabric 12. The tubular base 11,as shown in FIGS. 1-4, includes two interlocking arcuate members 13, 14.

The arcuate members 13, 14 are formed of a biocompatible polymericmaterial. Preferably, the arcuate members 13, 14 are formed ofpolyurethane or polypropylene. More preferably, the members 13, 14 areformed of Class 6 biocompatible polypropylene. Other suitablebiocompatible polymers for forming the arcuate members 13, 14 include,for example, polyethylene, homopolymers and copolymers of vinyl acetatesuch as ethylene vinyl acetate copolymer, polyvinylchlorides,homopolymers and copolymers of acrylates such as polymethylmethacrylate,polyethylmethacrylate, polymethacrylate, ethylene glycol dimethacrylate,ethylene dimethacrylate and hydroxymethyl methacrylate, polyurethanes,polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene,polycarbonates, polyamides, fluoropolymers such aspolytetrafluoroethylene and polyvinyl fluoride, polystyrenes,homopolymers and copolymers of styrene acrylonitrile, cellulose acetate,homopolymers and copolymers of acrylonitrile butadiene styrene,polymethylpentene, polysulfones, polyesters, polyimides,polyisobutylene, polymethylstyrene and other similar compounds known tothose skilled in the art. It should be understood that this list ofpossible biocompatible polymers is for exemplary purposes and should notbe construed as limiting.

The arcuate members 13, 14 are interconnected by a hinge 16 such thatthe first arcuate member 13 is movable with respect to the secondarcuate member 14 between a closed position as shown in FIGS. 1, 2 and 4and an open position as shown in FIGS. 3 and 3a. The hinge 16 ispreferably integral with the arcuate members 13, 14, and is formed bytapering the base 11 proximate to one of the side surfaces 18, 20 ofeach of the members 13, 14. The base 11 is tapered from the exteriorsurface 22 of the base 11 toward the interior surface 24 of the base 11proximate the side surfaces 18, 20 along the length of the base 11 suchthat a generally flat portion 26 is formed on the exterior surface 22 ofthe base 11 as best shown in FIGS. 1, 1a, 2 and 2a. At the point wherethe generally flat portion 26 is thinnest as measured from the exteriorsurface 22 to the interior surface 24, the base 11 becomes more easilybendable, forming a hinge 16.

The type of hinge 16 provided to the base 11 is not critical to theoperation of the cuff 10. While the particular hinge 16 described is thepreferred hinge 16, it should be understood by one of ordinary skill inthe art from this disclosure that the arcuate members 13, 14 may bejoined by other types of hinges without departing from the spirit of thepresent invention.

When the cuff 10 is in the closed position, the side surfaces 28, 30 ofthe arcuate members 13, 14 opposite the hinge 16 are coupled in agenerally facing relationship such that the base 11 is generally tubularas shown in FIGS. 1, 1a, 4, 4a. The base defines a preferablycylindrical passage 32 which extends longitudinally through the base 11of the cuff 10 in the closed position for receiving a catheter as shownin FIGS. 1 and 2.

When the base 11 of the cuff 10 is in the closed position, the sidesurfaces 28, 30 of the arcuate members 13, 14 are releasably lockable.In the embodiment shown in FIGS. 1-4, the preferred device for lockingthe arcuate members 13, 14 in the closed position is to provide the sidesurfaces 28, 30 of the arcuate members 13, 14 with interlocking segments34 which snap together by manually forcing the arcuate members 13, 14into the closed position. The interlocking segments 34 preferably openeasily when the arcuate members 13, 14 are pulled apart using areasonable amount of manual force. More preferably, the interlockingsegments 34 and side surfaces 28, 30 are arranged such that the arcuatemembers 13, 14 overlap. However, it is understood by those of ordinaryskill in the art from this disclosure that other locking devices may beused to securely lock the cuff 10 in the closed position, as long assomeone operating the cuff 10 is able to easily open it upon applicationof manual force. Suitable locking devices include, for example,interlocking pieces, a snap-fit device, a slidable locking ring,Velcro®, a latch, a hook and similar locking devices. Preferably thelocking device is made from a biocompatible polymeric material such asthose described above.

When the base 11 of the cuff 10 is in the open position, the sidesurfaces 28, 30 of the arcuate members 13, 14 are uncoupled and spacedfrom each other such that a space 36 is created between the members 13,14 which is sized to allow a catheter to fit through the space 36 forinsertion into the cuff 10.

The side surfaces 28, 30 of the arcuate members 13, 14 may have anyconfiguration as long as they are configured to couple together in theclosed position. For example, as shown in FIGS. 1a-4a the side surfaces28, 30 may extend along the length of the base in a continuous straightline such that each arcuate member 13, 14 has an approximatelyequivalent generally semi-circular cross section which is constant alongthe length of the base 11, the cross section taken along a planeperpendicular to the longitudinal axis of the base 11. Alternatively,the side surfaces 28, 30 may, for example, couple along a curved line ora straight line extending at an angle along the length of the base 11such that the cross section of the arcuate members is not constant alongthe length of the base 11.

In the embodiment shown in FIGS. 1-4, the side surfaces 28, 30 whencoupled preferably extend longitudinally along a generally straight linefor approximately one-half of the length of the base 11. The sidesurfaces 28, 30 are configured on this half 38 of the base 11 such thatthe cross sections of the arcuate members 13, 14 are constant along thehalf 38 of the base 11, but the arcuate member 14 has a cross sectionwhich is less than a semi,circle and the arcuate member 13 has a crosssection which is greater than a semi-circle. Halfway along the length ofthe base 11, the side surfaces then extend outwardly across a portion ofthe base 11 forming the interlocking segments 34 shown in FIGS. 1, 3 and4. After the last interlocking segment 34, the side surfaces 28, 30 thenextend along a generally straight line for the remaining half 40 of thebase 11. The side surfaces 28, 30 are configured on this half 40 of thebase 11 such that the cross sections of the arcuate members 13, 14 areconstant along the half 40, but the arcuate member 13 has a crosssection which is less than a semi-circle and the arcuate member 14 has across section which is greater than a semi-circle. This particularconfiguration creates overlapping arcuate members 13, 14.

When the side surfaces 28, 30 are configured in the manner shown, thearcuate members 13, 14 have protruding portions 42, 44 extendingoutwardly from the members 13, 14 which interlock such that theinterlocking segments 34 on each arcuate member 13, 14 may lock the cuff10 in the closed position. A top plan view of this configuration wouldshow protruding members 13, 14 which appear generally L-shaped.

Each arcuate member 13, 14, irrespective of the configuration of theside surfaces 28, 30 preferably has a suture hole 46 which is preferablylocated proximate to the side surfaces 28, 30. More preferably, theholes 46 are located near the area in which the side surfaces 28, 30couple when the base 11 is in, the closed position. If the edges 28, 30are configured as shown in FIGS. 1, 3 and 4, the suture holes 46 arepreferably located in the protruding portions 42, 44. More preferably,the suture holes 46 are located in the protruding portions 42, 44proximate to the side surfaces 28 , 30 and more preferably near thelocation in which the protruding portions 42, 44 interlock.

As shown in FIGS. 2 and 2a, the suture holes 46 are preferably taperedsuch that the diameters of the holes 46 are greater at the exteriorsurface 22 of the base 11 of the cuff 10 than the diameters of the holes46 at the interior surface 24 of the base 11 of the cuff 10.i The sutureholes 46 in the arcuate members 13, 14 proximate to the area in whichthe arcuate members are coupled preferably serve as an area ofattachment for a connecting material 48. A first end 50 of theconnecting material 48 is drawn through and tied to the suture hole 46in one arcuate member 13, and a second end 52 of the connecting material48 is drawn through and tied to the suture hole 46 in the other arcuatemember 14. It should be understood by those skilled in the art from thisdisclosure that the connecting material 48 can be fastened to themembers 13, 14 without using suture holes 46. The purpose of theconnecting material 48 is to form a loop 54, preferably an overlappingloop 54, in the cylindrical passage 32 of the base 11 which will tightenaround a catheter once the catheter is inserted in the passage 32. Theloop 54 should be sufficiently tight around the catheter such that thecatheter is secure within the passage 32, but not tight enough toconstrict the catheter such that free flow of bodily fluid is maintainedonce the catheter is secure within the passage 32.

If the side surfaces 28, 30 are configured as shown in FIGS. 1a-4a suchthat the arcuate members 13, 14 are equal semi-circular members asdescribed above, the length of the connecting material 48 extendingwithin the passage 32 as measured from the first end 50 to the secondend 52 may be less than the inner circumference of the base 11. However,the connecting material 48 may be of a longer length and overlappedwithin the passage 32. In addition, when the base 11 is configured tohave protruding interlocking portions 42, 44, the connecting material 48is preferably of a length which allows for tightening of the loop 54after the ends 50, 52 of the connecting material 48 have overlapped oneanother. Overlapping of the loop 54 provides a dynamic tighteningcapability to the connecting material 48. When overlapped as indicatedin FIG. 2, the loop 54 acts in a dynamic ratchet-like manner whentightening around a catheter 58 as shown in FIG. 4.

When the base 11 is open, a catheter is inserted between the arcuatemembers 13, 14 and on top of the connecting material 48. When the base11 is closed, the connecting material 48 is looped at least partially,and preferably completely, around the catheter. The connecting material48 tightens on the catheter within the base 11 and secures it within thepassage 32 of the cuff 10. The loop should be tight enough to secure thecatheter within the passage 32 while maintaining free flow of bodilyfluid through the catheter.

If the side surfaces 28, 30 are configured as shown in FIGS. 1-4,portions of the connecting material 48 near each end 50, 52 shouldoverlap within the passage 32 when the base 11 is in the closed positionforming a loop 54 within the passage 32 which tightens at leastpartially, and preferably completely, around a catheter 58 inserted inthe base 11 as shown in FIG. 4. A catheter is inserted in the base 11while the base 11 is in the open position by positioning it through thespace 36. The base 11 is then locked in the closed position and thecatheter secured within the tightened loop 54.

The length of the connecting material 48 may be similarly adapted forvarying side surface 28, 30 configurations and/or suture hole 46locations such that regardless of the design, when the catheter iswithin the passage 32 and the base 11 is closed, the connecting material48 forms a sufficiently tight loop at least partially, and preferablycompletely, around the inserted catheter to secure the catheter withinthe passage 32 of the cuff 10 while maintaining free flow of bodilyfluid through the catheter.

The connecting material 48 may be any non-dissolvable, biocompatiblematerial. Suitable non-dissolvable, biocompatible materials include, forexample, silk or nylon suture material, braided suture, multi-strandsuture, multi-strand braided suture, thread string and other similarmaterials. The preferred connecting material 48 is a non-dissolvablesuture material. Preferably, the suture material is a 1-0, 2-0, 3-0 or4-0 non-dissolvable braided suture. Other suitable sutures include, forexample, 1-0, 2-0, 3-0 and 4-0 polypropylene braided suture, 1-0, 2-0,3-0 and 4-0 Prolene monofilament or Epapbond braided synthetic sutures.It is understood by one skilled in the art that any non-dissolvable,biocompatible material may be used without departing from the scope ofthis invention.

Referring now to FIG. 4 and 4a, the exterior surface 22 of the base 11is preferably covered with a layer of fabric 12. The fabric 12 may beadhered to the exterior surface 22 by any suitable biocompatible medicalgrade adhesive. Preferably, Loctite Brand Medical Grade FMD No. 13 and14 adhesives are used. However, any biocompatible adhesive isacceptable.

Fabric 12 adhered to the exterior surface 22 functions to promoteingrowth of surrounding tissue cells into the cuff 10 once the cuff 10is positioned in an acceptable subcutaneous location and locked around acatheter inserted in an area to be catheterized. The fabric 12 may beany biocompatible fabric 12 suitable for promoting tissue ingrowth.Preferably, the fabric 12 is a tight-weave, low profile polyester suchas, for example, a Dacron® composite. It should be understood by thoseOf ordinary skill in the art from this disclosure that the fabric 12 tobe used may be selected in accordance with such factors as the area ofthe body in which the cuff 10 is to be placed and patient tolerance to aparticular fabric 12. It should also be understood that the cuff 10 maybe attached to the surrounding tissue by methods other than use of alayer of fabric 12, such as, for example, suturing the device in thepreferred location for securement

As shown in FIGS. 1-3 and 1a-3a, the base 11 of the cuff 10 may compriseone or more ribs 56 on the interior surface 24 of the base 11. The ribs56 extend radially inwardly into the passage 32. Once a catheter isinserted in the passage 32 and the cuff 10 is in the closed position asshown in FIGS. 4 and 4a, the ribs 56 function to provide slight pressureon the catheter 58 at the location of the ribs 56. The ribs 56 alsopreferably function to form a fluid seal and to prevent internalingrowth of tissue which may cause fouling within the base 11. The ribs56 may be of any geometric configuration including, for example,generally rounded, triangular or rectangular in cross section as long asthe ribs 56 are sufficiently smooth such that the catheter 58 is notdamaged or abraded. The ribs 56 may be located at any locationthroughout the length of the cuff 10. Preferably there is a rib 56proximate each end of the passage 32 as shown in FIGS. 1a, 3 and 3a toform a fluid seal and prevent fouling. In addition, the ribs 56preferably form a continuous annular ring on the interior surface 24 ofthe base 11 as shown in FIGS. 1-3 and 1a-3a. The ribs 56 may also takethe form of a non-continuous ring or individual protrusions spaced atvarying locations throughout the interior surface 24 of the base 11resembling raised dots. While such designs provide a tighteningfunction, they do not generally provide an adequate fluid seal.

In the preferred embodiment as shown in FIGS. 1-4 and 1a-4a, the base 11of the cuff 10 also includes a third suture hole 46'. The third suturehole 46' is spaced longitudinally from the suture holes 46 located inthe protruding sections 42, 44 of the arcuate members 13, 14.

As shown in FIG. 7, a catheter 60 is inserted in an area to becatheterized 62. A portion of the catheter 60 extending proximal to thearea to be catheterized is inserted in the passage 32 of the base 11 ofa cuff 10 having a third suture hole 46'. The cuff 10 is positioned in adesirable subcutaneous area 64 for securement. The base 11 is thenlocked in the closed position. A second piece of connecting material 66is attached at one end 68 to the third suture hole 46'. The other end 70of the connecting material 66 may be extended out of the body 72enabling the cuff 10 to be fastened to any secure source providingadditional stability to the catheter while it stabilizes within the areato be catheterized 62 or while tissue grows into the fabric 12.

A system of secured catheters 74 using the preferred cuff 10 is shown inFIG. 7. A second catheter 60' is inserted in a second area to becatheterized 62' and secured in a second subcutaneous area 64' by asecond cuff 10' having a third suture hole. A further piece of theconnecting material 66' is then fastened at one end 68' to the thirdsuture hole of the cuff 10'. The other end 70' may be fastened to anysecure source. As shown in FIG. 7, in a system of secured catheters 74in accordance with the present invention, the ends 70, 70' are fastenedto each other. After fastening the ends 70, 70' to each other, theconnecting material 66, 66' is released by the physician and locatedinternally such that there remains no external connecting material 66,66' in such a system.

Preferably, connecting material 66 attached to the third suture hole 46'of a cuff 10 and fastened to a secure source, such as another connectingmaterial 66' externally or internally, is a dissolvable connectingmaterial 66. Any suitable dissolvable connecting material may be used.Preferably, the connecting material 66 is a dissolvable material such asan Epapbond braided dissolvable suture.

The connecting material 66 performs the function of providing additionalstability to the cuff 10, while the cuff 10 and catheter stabilize inthe subcutaneous location. Although any connecting material may be used,dissolvable suture material is preferred. Therefore, it is not necessaryfor the connecting material 66 to be permanent, especially since theconnecting material 66 may be placed outside the body 72 of the patientwhere use of a non-dissolvable connecting material 66 may present apossibility of infection. In addition, while the material 66 may bepermanent at a physician's discretion in a particular case, it is notpreferred as it may increase the risk that bacteria may grow on thesuture and spread into the patient causing infection.

The method for subcutaneous securement of a catheter in accordance withthe present invention is performed using the cuff 10, as shown in FIGS.1-3 and 1a-3a. The method includes the step of inserting a distalportion of a catheter into an area to be catheterized. The catheter maybe any type known to those of ordinary skill in the art useful fordraining or exchanging bodily fluids. Typical catheters include, forexample, central venous and other intravenous catheters, shunts fordrainage of bodily cavities, Tesio catheters, Swan-Ganz catheters andother similar devices.

The area to be catheterized may be any area in the body such as, forexample, blood Vessels, including the femoral, jugular and subclavianveins, any abscess cavity, post-operative cavity, the peritoneal cavity,and other areas of the body including intra-abdominal, sub-diaphragmaticand sub-hepatic areas. It should be Understood by one of ordinary skillin the art from this disclosure that these areas are exemplary, and thatthe cuff 10 may be used to fasten any catheter or shunt inserted invarious subcutaneous areas to be catheterized. FIG. 7 shows two centralvenous catheters 60, 60' inserted in two subcutaneous areas 62, 62' tobe catheterized.

Once the distal portion of the catheter is within the area to becatheterized, the Cuff 10 is opened as shown in FIGS. 3 and 3a such thata space 36 is created between the arcuate members 13, 14 for insertionof a portion of the catheter proximal the distal portion inserted in thearea to be catheterized. Any portion of the catheter proximal the distalportion situated in the area to be catheterized may be inserted in thecuff 10, including portions of the cannula, hub area, extension tubes,or other related areas of the catheter proximal to the area to becatheterized. The proximal portion of the catheter is inserted in thespace 36 such that it is positioned between the arcuate members 13, 14.The connecting material 48 should be between the proximal portion of thecatheter and the interior surface 24 of the arcuate members 13, 14 ofthe cuff 10.

The cuff 10 is then moved by the physician along the proximal portion ofthe catheter until the cuff 10 is positioned in a stable area forsecurement. Areas for securement are determined by the physiciandepending upon the availability of tissue for attachment and ingrowth,effective alignment of the catheter within the subcutaneous area andease of access to the area in which the catheter is to be secured. Manyother factors, including the type of catheter, the part of the catheterto be secured, and the availability of subcutaneous area for securementwill enter into the choice of a stable area. It should be understoodthat choice of a stable area will largely be a function of thephysician's judgment in a particular medical situation.

Once an optimal area for securement is found, the physician stops movingthe cuff 10 along the catheter and moves the arcuate members 13, 14about the hinge 16 to the closed position such that the side surfaces28, 30 are coupled in a facing relationship. If the cuff 10 does notlock by snapping the members 13, 14 closed, the physician then locks thecuff 10 manually by manipulating any locking device provided. As shownin FIGS. 4 and 4a once the cuff 10 is locked, the catheter 58 isencircled in a tightened loop 54 of connecting material 48 andstabilized within the cuff 10. Preferably fabric 12 covering theexterior surface 22 of the base 11 then promotes ingrowth of surroundingtissue cells into the cuff 10. Alternatively, the physician may thenelect to suture or otherwise attach the cuff 10 to the surroundingtissue.

If the cuff 10 has a third suture hole 46', a second piece of connectingmaterial 66 as shown in FIG. 7 is then fastened at one end 68 to thethird'suture hole 46' and may be drawn out through the body 72 throughan opening created for insertion of the catheter 60 or through anopening made by a second incision if necessary. The second end 70 mayalso be left internally. In either case, the connecting material 66 isattached at the opposite end 70 to a secure source. The connectingmaterial 66 may also be attached to the end 70' of a second piece ofconnecting material 66' attached to a second cuff 10' in a secondsubcutaneous location 64'. Once attached, the two pieces of attachedconnecting material 66, 66' are closed within the body 72.

The cuff 10 remains in place, and is removed with the catheter aroundwhich it has been positioned. The cuff 10 may then be discarded alongwith the catheter.

An alternative embodiment of the cuff of the present invention is shownin FIGS. 5 and 6, and is generally indicated as 76. The cuff 76 includesfirst and second tubular members 78, 80. The tubular members 78, 80 maybe manufactured from any of the biocompatible polymeric materialsdiscussed above which are useful for manufacturing the arcuate members13, 14 of the cuff 10. The tubular members 78, 80 preferably have agenerally annular cross section, however, other cross sections such as,for example, elliptical, egg-shaped, oval, square and the like arewithin the scope of this invention. The second tubular member 80 has aninterior surface 82 which defines a preferably generally cylindricalpassage 84 extending longitudinally through the member 80. The firsttubular member 78 has an interior surface 86 which also defines apreferably generally cylindrical passage 88 extending longitudinallythrough the first tubular member 78.

The second tubular member 80 has an inner diameter which is larger thanthe outer diameter of the first tubular member 78, and the first andsecond tubular members 78, 80 are positioned such that at least aportion of the first tubular member 78 lies within the passage 84. Aspace 90 is created between the first and second tubular members 78, 80which is preferably generally annular.

While the first and second tubular members 78, 80 may have the samelength, it is preferred that the tubular members 78, 80 be of differentlengths to facilitate rotation of the cuff 76 by the physician once thecuff 76 is properly positioned. More preferably, the second tubularmember 80 has a smaller length than the length of the first tubularmember 78. When the first tubular member 78 is placed around a catheter92 as shown in FIG. 6 its longer length allows the physician to grip thefirst tubular member 78 while rotating the second tubular member 80around the first tubular member 78. The second tubular member 80, whichis preferably covered by a layer of fabric 94 for ingrowth ofsurrounding tissue cells into the cuff 76 preferably has a widerdiameter than the first member 78. It should be understood by one ofordinary skill in the art from this disclosure that the members 78, 80may have varying or equivalent lengths without departing from the spiritof this invention.

Fabric 94 may be adhered to the tubular member 78 by any biocompatiblemedical grade adhesive known in the art such as those described aboveuseful for attaching the fabric 12 to the base 11 of the cuff 10.

A hole 96, preferably a suture hole 96 is made through the first tubularmember 78 and preferably through the second tubular member 80.Preferably, the suture holes 96 extend from the exterior surface 98, 100to the interior surface 86, 82 of each member 78, 80. Preferably, thesuture holes 96 are tapered as described above for the suture holes 46in the cuff 10. Connecting material 102 made of the same material as theconnecting material 48 is attached at one end 104 to the interiorsurface 86 of the tubular member 78. The end 104 may be fastened by anysuitable means. For example, the end 104 may preferably be affixed tothe interior surface 86 by a medical grade adhesive material.Alternatively, a second suture hole (not shown) may preferably be madein the first tubular member 78 and the end 104 may be knotted in theannular space 90 such that the connecting material 102 then extends downthrough the second suture hole into the passage 88.

The connecting material 102 is twisted to form a loop 105 of thematerial 102 within the passage 88. The second end 106 of the connectingmaterial 102 is passed outwardly through the suture hole 96 in thetubular member 78 and either fastened to the second tubular member 80 byadhesive or preferably passed outwardly through a suture hole 96 in thesecond tubular member 80 such that it extends beyond the exteriorsurface 100 of the second tubular member 80. The end 106 is preferablyknotted or adhered to the exterior surface 100 by adhesive. Theconnecting material 102 is positioned such that when a catheter 92 isplaced within the loop 105 and the second tubular member 80 is rotatedwith respect to the first tubular member 78 as shown in FIG. 6, aportion of the connecting material 102 from the passage 88 is drawnthrough the space 90 and the loop 105 tightens around the catheter 92.The catheter 92 is thus secured within the passage 88. As discussed withrespect to the cuff 10, the loop 105 should be tight enough to securethe catheter 92 within the passage 88, but not tight enough to constrictthe catheter 92. Free flow of bodily fluid through the catheter 92should be maintained. The loop 105 is preferably overlapping such thatupon rotation of the first tubular member 78, the loop 54 tightens in adynamic manner around the catheter 92.

The cuff 76, like the cuff 10 may include optional ribs as describedabove on the interior surface 86 of the first tubular member 78.

The cuff 76 preferably includes a locking device, such as, for example,an interlocking button 108 as shown in FIGS. 5 and 6. The button 108 islocated on the exterior surface 98 of the first tubular member 78. Thebutton 108 is movable in response to pressure until the cuff 76 has beenrotated to tighten the loop 105. Once the cuff 76 has been rotated intoposition, the button snaps into a recessed mating hole 110 provided tothe interior surface 82 of the second tubular member 80 to preventfurther rotation of the cuff 76 thereby locking it into position.Alternatively, a latch or snap fitting for may be used to providestability while the surrounding cells grow into the fabric 94.

An optional third suture hole spaced longitudinally from the sutureholes 96 may be made in the first tubular member 78 of the cuff 76 suchthat the cuff 76 can be fastened to a secure source or used in a systemfor subcutaneously securing more than one catheter in an area to becatheterized as previously described with respect to the cuff 10.

An alternative preferred method for securement of a catheter in an areato be catheterized preferably uses the cuff 76. A distal portion of acatheter must be inserted in an area to be catheterized as describedabove using any suitable method. A loop 105 of connecting material 102is formed in the passage 88 of a cuff 76 as shown in FIG. 5. A portionof the catheter proximal to the distal portion inserted in the area tobe catheterized is inserted in the loop 105. The loop 105 and cuff 76are moved along the catheter until the cuff 76 is situated in apreferred area for subcutaneous securement as described above.

Once the cuff is preferably situated, the first tubular member 80 isrotated with respect to the second tubular member 78 such that a portionof the connecting material 102 from within the passage 88 is pulledthrough the space 90 and the loop 105 is tightened around the catheter92 thereby securing the catheter 92 Within the passage 88 andmaintaining free flow of bodily fluid through the catheter 92.Preferably, the cuff 76 is locked in place to prevent further rotationof the tubular members 78, 80. Preferably, fabric 94 adhered to theexterior surface 100 of the second tubular member 80 is allowed topromote ingrowth of surrounding tissue into the device for long termsecurement of the catheter. Alternatively, the physician may attach thecuff 76 to the surrounding tissue by any suitable method, such as, forexample, suturing.

The cuff 76 is removed when the catheter is withdrawn from the body 72,and the cuff 76 is disposable along with the catheter.

An alternative embodiment of the cuff of the present invention is shownin FIGS. 8, 9 and 10, and is generally indicated as 112. The cuff isformed of an elastic base 114 and a connecting material 116.

The elastic base 114 may be moved from a flexed open position as shownin FIG. 8 to a relaxed closed position as shown in FIG. 10. The base 114may be made of any flexible biocompatible thermoplastic polymer such as,for example, polypropylene, polyethylene and polyurethane. Morepreferably, the base 114 is formed from a preformed medical gradepolypropylene such as the Class 6 biocompatible polypropylene describedabove with respect to the arcuate members 13, 14 of the cuff 10.However, the polypropylene base 114 should be preformed in the relaxedclosed position to impart flexibility and elasticity to the base 114such that when the base 114 is moved by application of manual force tothe flexed open position, it returns to the relaxed closed position uponremoval of the applied force. Any biocompatible polymer, such as thoselisted above as suitable for manufacture of the arcuate members 13, 14,may be used to manufacture the base 114; however, it will be understoodby those of ordinary skill in the art that the polymeric materialselected should be of sufficient flexibility such that it may bepreformed to provide elastic movement to the base 114. Preferably,polymers having a high level of rigidity or stiffness upon molding arenot used for forming the base 114.

Preferably, the base 114 is preformed and flexible such that in therelaxed positions, it is in a closed tubular position as shown in FIG.10 in which the first side surface 118 and the second opposite sidesurface 120 are proximate each other and a passage 121 for receiving acatheter is formed. Preferably, the side surfaces 118, 120 are in facingengagement when the base 114 is in the relaxed position. When the base114 is flexed open, for example by manual force, the side surfaces 118,120 are then separated from each other leaving a space 122 between them.

The connecting material 116 is preferably drawn at a first end 124 fromthe interior surface 125 of the base 114 through a first suture hole 126spaced from the side surface 118 to the exterior surface 127. The secondend 128 of the connecting material 116 is drawn from the interiorsurface 125 of the base 114 through a second suture hole 130 spaced fromthe side surface 120 to the exterior surface 127 of the base 114.

Preferably, when the ends 124, 128 of the material 116 are drawn throughthe suture holes 126, 130, the ends 124, 128 are knotted such that theconnecting material does not pass back through the holes 126, 130.

The material 116 may also be connected to the interior surface 125 ofthe base 114, for example, by adhering the ends 124, 128 to the interiorsurface 125 of the base 114 with any acceptable medical grade adhesivesuch as those described above instead of drawing the ends 124, 128through the suture holes 126, 130. If the ends 124, 128 are connected tothe interior surface 125 of the base 114, the connecting material 116must be of a length which would sufficiently tighten to assist insecuring the catheter 132 within the cuff 112.

While the base is in the flexed open position as shown in FIG. 8, aportion of a catheter 132, proximal a distal portion (not shown) of thecatheter 132 inserted in an area to be catheterized (not shown), may beinserted in the space 122 such that the portion of the catheter 132 isbetween the connecting material 116 and the interior surface 125 of thebase 114.

At this point, the base 114 may be released from any application offorce such that it returns to a relaxed position as shown in FIG. 10 andthe catheter 132 is within the passage 121. The ends 124, 128 are thenfastened together, preferably by tying the ends 124, 128 in a knot 134,such that the connecting material 116 forms at least a portion of a loop138 which at least partially surrounds the catheter 132. Preferably theloop 138 is an overlapping loop as shown in FIGS. 9 and 10. Anoverlapping loop 138 is preferably formed by first rotating the base 114with respect to the catheter 132 as shown in FIG. 9 about 180° prior toreleasing the base 114 to return the base 114 to the relaxed position.An overlapping loop 138 provides a similar dynamic tightening functionas the overlapping of the loops 54, 105 in the other embodiments of thisinvention. If the loop 138 is not overlapping, the suture holes 126, 130should be spaced from the side surfaces 118, 120 such that when the ends124, 128 are drawn together and fastened, the connecting material formsa partial loop 138 which effectively clamps the catheter 132 within thedevice (not shown).

When the ends 124, 128 are fastened, preferably forming an overlappingloop 138, the connecting material 116 is tightened around the catheter132. The connecting material 116 should be drawn along the exteriorsurface 127 of the base 114 and the ends 124, 128 tied to ether suchthat the connecting material 116 is tight enough to secure the catheter132 within the passage 121, but free flow of bodily fluid through thecatheter 132 is maintained.

Like the cuff 10 and alternative cuff 76, the cuff 112 is alsopreferably covered with an outer layer of fabric (not shown) to promoteingrowth of surrounding tissue cells into the cuff 112. In addition, thecuff 112 may have an optional third suture hole (not shown) spacedlongitudinally from the suture holes 132, 134 such that the cuff 112 canbe fastened to a secure source or used in a system for subcutaneouslysecuring more than one catheter in an area to be catheterized aspreviously described with respect to the cuffs 10, 76.

A further alternative method for securing a catheter in an area to becatheterized preferably uses the cuff 112. A distal portion of acatheter is inserted in an area to be catheterized in the manner shownin FIG. 7. The base 114 is moved to and maintained in the flexed openposition as shown in FIG. 8. A portion of the catheter 132 proximal thedistal end inserted in the area to be catheterized is inserted betweenthe connecting material 116 and the base 114 as shown in FIG. 8. Atleast a portion of a loop 138 which at least partially surrounds thecatheter 32 is then formed and the base 114 is then released such thatit moves to the relaxed closed position. The first and second ends 124,128 of the connecting material 116 are then fastened together,preferably by tying the ends 124, 128 into a knot 134 to tighten theconnecting material 116 around the catheter 132 and to secure thecatheter 132 within the base 114 while maintaining free flow of bodilyfluid through the catheter 132.

Preferably, the base 114 is rotated with respect to the catheter 132 asshown in FIG. 9 about 180° prior to releasing the base 114 from theflexed open position such that the connecting material 116 forms anoverlapping loop 138 around the catheter 132. The ends 124, 128 are thenpreferably tied together to secure the catheter 132 within the cuff 112.

In the preferred method, the catheter 132 is maintained securely withinthe cuff 112 until surrounding tissue cells grow into a fabric layer(not shown) adhered to the exterior surface 127 of the base 114.Alternatively, the cuff 112 may be held in place within the subcutaneousarea to be secured by any suitable means as described above with respectto the cuff 10.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed but itis intended to cover modifications within the spirit and scope of thepresent invention as defined by the appended claims.

I claim:
 1. A locatable device for subcutaneous securement of a catheterin an area to be catheterized, comprising:(a) a first arcuate memberhaving an exterior surface, an interior surface, and a side surface; (b)a second arcuate member having an exterior surface, an interior surface,and a side surface; (c) a hinge interconnected between the first arcuatemember and the second arcuate member such that the first arcuate memberis movable with respect to the second arcuate member between a closedposition wherein the side surface of the first arcuate member and theside surface of the second arcuate member are coupled in facingrelationship forming a tubular base, said tubular base dimensioned forsubcutaneous placement and defining a passage extending longitudinallytherethrough for receiving a catheter therein and an open positionwherein the first and second arcuate members are uncoupled and at leastpartially spaced from each other, the side surface of the first arcuatemember and the side surface of the second arcuate member beingreleasably lockable in the closed position; and (d) a connectingmaterial extending within the passage, the material having a first endfastened to the first arcuate member and a second end fastened to thesecond arcuate member, the connecting material configured for forming atightened loop at least partially around a catheter received in thepassage thereby securing the catheter within the device and maintainingfree flow of bodily fluid through the catheter.
 2. The device accordingto claim 1, further comprising fabric adhered to the exterior surfacesof the first and-second arcuate members for promoting ingrowth ofsurrounding tissue cells when the catheter is secured within the device3. The device according to claim 2, wherein the fabric comprises atight-weave polyester.
 4. The device according to claim 1 furthercomprising at least one rib located on the interior surface of the firstand second arcuate members, the at least one rib extending radiallyinwardly for providing pressure on the catheter received within thepassage and for preventing ingrowth of tissue within the device.
 5. Thedevice according to claim 1, wherein the first and second arcuatemembers Are comprised of a biocompatible plastic material
 6. The deviceaccording to claim 1, wherein the first arcuate member is releasablylockable to the second arcuate member in the closed position byinterlocking segments located on the side surfaces of the first andsecond arcuate members.
 7. The device according to claim 1, wherein theconnecting material is a non-dissolvable suture material.
 8. The deviceaccording to claim 1, wherein the first end of the connecting materialis fastened to a first suture hole in the first arcuate member and thesecond end of the connecting material is fastened to a second suturehole in the second arcuate member.
 9. The device according to claim 8,wherein the suture holes are tapered such that diameters of the firstand second suture holes are greater at the exterior surfaces of thefirst and second arcuate members than diameters of the first and secondsuture holes at the interior surfaces of the first and second arcuatemembers.
 10. The device according to claim 8, further comprising a thirdsuture hole, the third suture hole spaced longitudinally from the firstand second suture holes such that when the device is in the closedposition, a second connecting material is fastened at a first end to thethird suture hole and fastened at a second end to a secure source. 11.The device according to claim 10, wherein the second connecting materialis a dissolvable suture material.
 12. A system for securing a firstcatheter and a second catheter in a first and second subcutaneous areato be catheterized, comprising a first device as in claim 10 for closingaround the first catheter inserted in the first area to be catheterizedand a second device as in claim 10 for closing around the secondcatheter inserted in the second area to be catheterized, wherein thesecond ends of the second connecting material are fastened together. 13.The device according to claim 8, wherein the first suture hole islocated proximate to the side surface of the first arcuate member andthe second suture hole is located proximate to the side surface of thesecond arcuate member.
 14. The device according to claim 1, wherein thefirst arcuate member includes a first protruding portion extendingoutwardly from the first arcuate member and the second arcuate memberincludes a second protruding portion extending outwardly from the secondarcuate member, the first and second protruding portions beinginterlocked when the device is in the closed position, the side surfacesof the first and second arcuate members are in a mating relationship andthe first end and the second end of the connecting material overlapforming a loop of connecting material around the catheter.
 15. Thedevice according to claim 14, wherein a first suture hole is in thefirst protruding portion and a second suture hole is in the secondprotruding portion.
 16. The device according to claim 15, wherein thefirst suture hole is located proximate to the side surface of the firstarcuate member and the Second suture hole is located proximate to theside surface of the second arcuate member.
 17. The device according toclaim 15, further comprising a third suture hole, the third suture holespaced longitudinally from the first and second suture holes such thatwhen the device is in the closed position, a second connecting materialis fastened at a first end to the third suture hole and fastened at asecond end to a secure source.
 18. A system for securing a firstcatheter and a second catheter in a first and second subcutaneous areato be catheterized, comprising a first device as in claim 17 for closingaround the first catheter inserted in the first area to be catheterizedand a second device as in claim 16 for closing around the secondcatheter inserted in the second area to be catheterized, wherein thesecond ends of the second connecting materials are fastened together.